Onxeo S.A., an innovative company specializing in the development of orphan oncology drugs, announced compliance and patient acceptability results from a global Phase 2 clinical trial demonstrating daily treatment application of Validive® (Clonidine Lauriad®), a mucoadhesive buccal tablet for the prevention and treatment of chemo-radiation therapy-induced severe oral mucositis (SOM) in patients with head and neck cancer, is well-accepted and well-tolerated by patients, with high compliance, before and throughout chemoradiotherapy treatment.
Results of the study, "Compliance and Patient Acceptability of Clonidine Mucoadhesive Buccal Tablet (Clonidine Lauriad) to Prevent Severe Radiomucositis in Head and Neck Cancer Patients" (Presentation # 1139), were presented by investigator Dr. Jordi Giralt, M.D., Ph.D., Head of the Radiation Oncology Service at Vall d'Hebron University Hospital in Barcelona, Spain, during the ePoster 16 Discussion Session "Head and Neck V" at the 57th American Society for Radiation Oncology (ASTRO) Annual Meeting, being held October 18-21, 2015 in San Antonio, TX.
Judith Greciet, Chief Executive Officer of Onxeo, commented, "These results establish that patient treatment compliance with Validive® is high and consistent between investigator and patient assessment. Compliance is key in the treatment of a lasting condition such as severe oral mucositis, about 5 to 8 weeks, as patients' acceptability is critical to ensure optimal efficacy."
The compliance and acceptability portion of the study found the mean overall patient compliance, calculated as the number of tablets taken as an expression for treatment duration in days, to be 95% (95% confidence interval), with median of 98%. The median duration of tablet adherence was 9 hours. Incidence of detachment of the tablet within the 6 hours was 17.1% and replacement of detached tablets with a new tablet was 41.5%. Tablet detachment and replacement rates were higher during the first weeks of the study, suggesting a learning curve. Overall compliance according to the patient diaries was similar in all treatment groups and consistent with the compliance according to the investigator's evaluation (mean of 89% [95%CI], with median of 98%). Overall mean values, at 95% confidence interval, of comfort, pain-burning and taste according to the daily patient scale from 0 to 10, were respectively 1.36, 1.18 and 1.16 and were not different between treatment groups.
These findings follow efficacy and safety results from the global Phase 2 randomized double-blind, placebo-controlled trial, which were presented at the 2015 ASCO Annual Meeting in May, that confirmed Validive® reduced the incidence and delayed the time to chemo-radiation therapy-induced SOM, with minimal toxicity, compared to placebo in 183 patients with head and neck cancer patients undergoing chemoradiotherapy.